ABSTRACT
On December 19, 2012, the U.S. Food and Drug Administration (FDA) informed health-care professionals and the public that Pradaxa (dabigatran etexilate mesylate, an anticoagulant) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves. Results from a recently stopped trial in Europe found that Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than users of another anticoagulant (warfarin). The observations led to a contraindication of Pradaxa in patients with mechanical heart valves (https:// www.fda.gov/Drugs/DrugSafety/ucm332912.htm?source=govdelivery).
